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Extrapolation in Practice: Lessons from 10 Years with Biosimilar Filgrastim

Biosimilar filgrastim (Sandoz) was approved in Europe in 2009 and, in 2015, was the first biosimilar approved in the USA. These authorizations were based on the “totality of evidence” concept, an approach that considers data from structural and functional characterization and comparability analysis and non-clinical and clinical studies. For biosimilar filgrastim, phase III...

Systematic Review and Meta-analysis of Short- versus Long-Acting Granulocyte Colony-Stimulating Factors for Reduction of Chemotherapy-Induced Febrile Neutropenia

Cornes has received honoraria from Accord Healthcare, Amgen, Hospira/Pfizer Inc, Medicines for Europe/European Generics Medecines Association, Roche, Sandoz, and Teva Pharmaceutical Industries Ltd. Pere ... Gascon has provided consultancy/advisory services (uncompensated) for Hospira. Steve Chan and Khalid Hameed have nothing to disclose. Polly Field is Communications Director at PharmaGenesis Oxford Central

Presently available biosimilars in hematology-oncology: G-CSF

Pere Gascon 0 ) Division of Medical Oncology, Hospital Clinic , IDIBAPS, University of Barcelona , Barcelona, Spain Biopharmaceuticals were copies of endogenous human proteins developed in the mid

Darbepoetin alfa for treating chemotherapy-induced anemia in patients with a baseline hemoglobin level < 10 g/dL versus ≥10 g/dL: an exploratory analysis from a randomized, double-blind, active-controlled trial

darbepoetin alfa-treated CIA patients who were categorized into baseline-Hb strata of < 10 g/dL or 10 g/dL at initiation of ESA therapy. In this analysis, darbepoetin alfa administered 500 mcg Q3W or Pere ... Gascon has received honoraria from Amgen Inc. for 2.25 mcg/kg QW raised Hb levels in both baseline-Hb groups while still maintaining mean Hb levels below 12 g/dL as recommended by the EU ESA product

A Dual Role for KRT81: A miR-SNP Associated with Recurrence in Non-Small-Cell Lung Cancer and a Novel Marker of Squamous Cell Lung Carcinoma

MicroRNAs (miRNAs) play an important role in carcinogenesis through the regulation of their target genes. miRNA-related single nucleotide polymorphisms (miR-SNPs) can affect miRNA biogenesis and target sites and can alter microRNA expression and functions. We examined 11 miR-SNPs, including 5 in microRNA genes, 3 in microRNA binding sites and 3 in microRNA-processing machinery...